MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 14FR 10ML TEMP SENS SIL UM MF

Catalog Number	UROT1100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rn was drawing clean catch urine sample off of foley catheter, and when rn disconnected the syringe, the foley sampling port came off of the catheter tubing".
Additional Manufacturer Narrative
The customer reported sample port detachment while the rn was drawing a clean catch urine sample off of a foley catheter; no medical intervention was necessary.Medline quality received 1 ea of the reported product in unpackaged, used condition, and visual assessment revealed that the sample port was seated within the sample port housing and the valve was able to be easily pulled out of the housing.The reported issue was verified, and it was noted that the valve stem had a lack of glue on the stem.The vendor was able to reproduce the results when an insufficient amount of glue is applied to the stem before attaching the valve to the sample port housing, attributed this issue to employee training, and reported that operators will be trained and the aql will be tightened for inspection.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: 14FR 10ML TEMP SENS SIL UM MF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50671287
• Report Number: 1417592-2026-33866
• Device Sequence Number: 10234804
• Product Code: OHR
• UDI-Device Identifier: 10193489491081
• UDI-Public: 10193489491081
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UROT1100
• Device Lot Number: 0332201A048
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown